Methods and devices for bone preparation

ABSTRACT

A manifold has at least one manifold aperture extending therethrough and selectively placed in fluid communication with a fluid source. An insertion structure has at least one interior cavity at least partially defined by a structure shell and is selectively placed in fluid communication with a corresponding manifold aperture. The insertion structure is configured for selective placement in a penetrating relationship with a patient tissue below a surface of the patient tissue. At least one shell perforation extends through the structure shell and places the interior cavity in fluid communication with a surrounding ambient space. At least one fluid path extends from the fluid source, through the manifold aperture, into the interior cavity, through at least one shell perforation, and at least one of a proximate relationship and a contacting relationship with the patient tissue beneath the outer surface thereof. A fluid is directed along the fluid path.

RELATED APPLICATION

This application claims priority from U.S. Provisional Application No.61/473,805, filed Apr. 10, 2011, the subject matter of which isincorporated herein by reference in its entirety.

TECHNICAL FIELD

The present invention relates to an apparatus and method for use of abone preparation device and, more particularly, to methods and devicesfor bone preparation which assist with supplying fluid to, or removingfluid from, the bone surface.

BACKGROUND OF THE INVENTION

The stability of an implant in bone may be determined by the shape ofthe implant, the quality of the bone, and/or the preparation of thesurgical site. In many cases, the bone quality may be weakened due toaging or disease. Weakened bone—or even normal cancellous (i.e., porous)bone—may lack sufficient support for traditional implantationtechniques. As one solution, the bone may be augmented with bone graftin the area around a space made for placement of the implant, which mayperformed by impaction grafting of cancellous autograft or allografttissue and/or the addition of a bone graft substitute. As anotherapproach, the implant may be fixed by adding bone cement to the cavity,potentially under pressure to assist penetration of the bone cement adistance from the space created for the implant and/or against thesurrounding tissue. Traditional methods may not provide sufficientaccess for preparing bone or adding bone augmentation materials.

Traditional systems and techniques for bone preparation may not reachthe areas in which the implant is positioned and may cause tissuebleeding between the preparation of bone and implantation of theimplant. Traditional techniques may be more complex and time consuming,lack the characteristic of being employed with precision, be damaging totissue, and/or fail to provide for proper preparation of weakened and/orcancellous bone, for example, at a site distant from the bonesurrounding the implant or around the cavity in the bone created by thebroach or instrument. As such, there is a need for an apparatus andmethod for preparing, accessing, and/or fastening to, for example, weakand/or cancellous tissue, such as an apparatus for preparing bone tissuedeep into the surface of the bone including sites that surround theimplant but are a distance from the bone immediately around the implant.

SUMMARY OF THE INVENTION

In an embodiment of the present invention, an apparatus for patienttissue preparation is described. A manifold has at least one manifoldaperture extending therethrough. The manifold aperture is selectivelyplaced in fluid communication with a fluid source. An insertionstructure has at least one interior cavity at least partially defined bya structure shell. The interior cavity is selectively placed in fluidcommunication with a corresponding manifold aperture. The insertionstructure is configured for selective placement in a penetratingrelationship with a patient tissue below a surface of the patienttissue. At least one shell perforation extends through the structureshell and places the interior cavity in fluid communication with asurrounding ambient space. When the insertion structure is in thepenetrating relationship with the patient tissue, at least one fluidpath extends from the fluid source, through the manifold aperture, intothe interior cavity, through at least one shell perforation, and atleast one of a proximate relationship and a contacting relationship withthe patient tissue beneath the outer surface thereof. A fluid isdirected along the fluid path to perform a patient tissue preparationtask.

In an embodiment of the present invention, a method for patient tissuepreparation is described. A manifold having at least one manifoldaperture extending therethrough is provided. The manifold aperture isplaced in fluid communication with a fluid source. An insertionstructure is provided, having at least one interior cavity at leastpartially defined by a structure shell. The interior cavity is placed influid communication with a corresponding manifold aperture. Theinsertion structure is selectively placed in a penetrating relationshipwith a patient tissue below a surface of the patient tissue. At leastone shell perforation extending through the structure shell is provided.The interior cavity is placed in fluid communication with a surroundingambient space through at least one shell perforation. When the insertionstructure is in the penetrating relationship with the patient tissue, atleast one fluid path is created extending from the fluid source, throughthe manifold aperture, into the interior cavity, through at least oneshell perforation, and into at least one of a proximate relationship anda contacting relationship with the patient tissue beneath the outersurface thereof. A fluid is directed along the fluid path to perform apatient tissue preparation task.

In an embodiment of the present invention, a prosthetic implantcomponent installation system is described. A manifold has at least onemanifold aperture in a surface thereof. The manifold aperture isselectively placed in fluid communication with a fluid source. Animplant structure has at least one interior cavity at least partiallydefined by a relatively thin-walled structure shell such that a higherpercentage of the total implant structure volume is dedicated tointerior cavity space than is provided by the structure shell. Theinterior cavity is selectively placed in fluid communication with acorresponding manifold aperture. The implant structure is configured forselective placement in a penetrating relationship with a patient tissuebelow a surface of the patient tissue to provide an ongoing, at leastsemi-permanent therapeutic function to the patient tissue. The implantstructure is selectively mated with the manifold during a surgicalprocedure for fluid communication therewith. The manifold is removedfrom the mating relationship with the implant structure before thesurgical procedure concludes. At least one shell perforation extendsthrough the structure shell and places the interior cavity in fluidcommunication with a surrounding ambient space. When the implantstructure is in the penetrating relationship with the patient tissue andthe manifold is mated with the implant structure, a plurality ofseparate fluid paths are each defined through a chosen manifoldaperture, into a corresponding chosen interior cavity, through at leastone shell perforation of the chosen interior cavity, and into at leastone of a proximate relationship and a contacting relationship with thepatient tissue beneath the outer surface thereof. A fluid is directedalong at least one fluid path to perform a patient tissue preparationtask.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the invention, reference may be made tothe accompanying drawings, in which:

FIG. 1 is a partial side view of an example use environment for thepresent invention;

FIG. 2 is a partial side view of an embodiment of the present inventionin the use environment of FIG. 1;

FIG. 3 is a partial side view of the embodiment of FIG. 2 in the useenvironment of FIG. 1;

FIG. 4 is a partial side view of the embodiment of FIG. 2 in the useenvironment of FIG. 1;

FIG. 5 is a partial side view of the embodiment of FIG. 2 in the useenvironment of FIG. 1;

FIG. 6 is a top view of an embodiment of the present invention;

FIG. 7 is a side view of an embodiment of the present invention;

FIG. 8 is a side view of an embodiment of the present invention;

FIG. 9 is a side view of an embodiment of the present invention;

FIG. 10 is a side view of the embodiment of FIG. 9 in an example useenvironment;

FIG. 11 is a perspective top view of an embodiment of the presentinvention;

FIG. 12A is a side view of an embodiment of the present invention in anexample use environment;

FIG. 12B is a side view of an embodiment of the present invention in theexample use environment of FIG. 12A;

FIG. 13A is a side view of an embodiment of the present invention in anexample use environment;

FIG. 13B is a side view of an embodiment of the present invention in theexample use environment of FIG. 13A;

FIG. 13C is a side view of an embodiment of the present invention in theexample use environment of FIG. 13A;

FIG. 14 is a side view of an embodiment of the present invention in anexample use environment;

FIG. 15A is a side view of an embodiment of the present invention in anexample use environment;

FIG. 15B is a side view of an embodiment of the present invention in theexample use environment of FIG. 15A;

FIG. 15C is a side view of an embodiment of the present invention in theexample use environment of FIG. 15A;

FIG. 15D is a side view of an embodiment of the present invention in theexample use environment of FIG. 15A;

FIG. 15E is a side view of an embodiment of the present invention in theexample use environment of FIG. 15A;

FIG. 16 is a side view of an embodiment of the present invention;

FIG. 17 is a cross-section taken along line 17-17 in FIG. 16;

FIG. 18 is a cross-section taken along line 18-18 in FIG. 17;

FIG. 19 is a partial perspective view of the embodiment of FIG. 16;

FIG. 20A is a first side view of an example use environment for thepresent invention;

FIG. 20B is a second side view of the example use environment of FIG.20A;

FIG. 21 is a top perspective view of an embodiment of the presentinvention;

FIG. 22 is a top perspective view of the embodiment of FIG. 21 in theexample use environment of FIG. 20B;

FIG. 24 is a side view showing the embodiment of FIG. 21 in the useenvironment of FIG. 20B;

FIG. 24 is a bottom view of an example configuration of a component ofan embodiment of the present invention;

FIG. 25 is a bottom view of an example configuration of a component ofan embodiment of the present invention;

FIG. 26 is a side view of an example use environment for the presentinvention;

FIG. 27 is a side view of an embodiment of the present invention in theexample use environment of FIG. 26;

FIG. 28 is a top view of the embodiment of FIG. 27 in the example useenvironment of FIG. 26;

FIG. 29 is a side view of an embodiment of the present invention in theexample use environment of FIG. 26;

FIG. 30 is a side view of an embodiment of the present invention in theexample use environment of FIG. 20A;

FIG. 31 is a side view of an embodiment of the present invention in anexample use environment;

FIG. 32 is a side view of an embodiment of the present invention in anexample use environment;

FIG. 33A is a side view of a tool for use with an embodiment of thepresent invention;

FIG. 33B is a top perspective view of the tool of FIG. 33A;

FIG. 34 is a side perspective view of a tool for use with an embodimentof the present invention;

FIG. 35 is a side perspective view of a tool for use with an embodimentof the present invention;

FIG. 36 is a side view of a tool for use with an embodiment of thepresent invention;

FIG. 37A is an exploded side view of a tool for use with an embodimentof the present invention;

FIG. 37B is a perspective bottom view of the tool of FIG. 37A;

FIG. 37C is a cross-sectional view taken along line C-C of FIG. 37B;

FIG. 38A is a top perspective view of an alternate configuration of thetool of FIG. 37A;

FIG. 38B is a cross-sectional view taken along line B-B of FIG. 38A;

FIG. 38C is a side view of the tool of FIG. 38A;

FIG. 39A is a side view of a tool for use with an embodiment of thepresent invention;

FIG. 39B is a bottom perspective view of the tool of FIG. 39A;

FIG. 40A is a side view of a tool for use with an embodiment of thepresent invention;

FIG. 40B is a side view of an alternate configuration of the tool ofFIG. 40A;

FIG. 41 is a side view of a tool for use with an embodiment of thepresent invention;

FIG. 42A is a side perspective view of an embodiment of the presentinvention;

FIG. 42B is a cross-sectional view taken along line B-B of FIG. 42A;

FIG. 43A is a side perspective view of an alternate configuration of theembodiment of FIG. 42A;

FIG. 43B is a cross-sectional view taken along line B-B of FIG. 43A;

FIG. 44A is a side perspective view of the embodiment of FIG. 42A;

FIG. 44B is a cross-sectional view taken along line B-B of FIG. 44A;

FIG. 44C is a cross-sectional view taken along line C-C of FIG. 44A and44B;

FIG. 44D is a side perspective view of the embodiment of FIG. 43A; and

FIG. 45 is a side view of the embodiment of FIG. 42A.

DESCRIPTION OF EMBODIMENTS

Devices and methods of the present disclosure may be applied to anypatient tissue surface, such as a cancellous bone surface, for any typeof surgery, including, but not limited to, an implant for jointreconstruction, joint replacement, fracture fixation, or any other jointor spinal procedure. For example, embodiments may be used for theproximal humerus metaphysis for a shoulder arthroplasty that may obtainfixation from the metaphyseal and or diaphyseal bone. The final implantwithin the metaphysis may allow for the application of any articulatingdevice for shoulder replacement. Embodiments may include placement of aspherical or semi-elliptical head or a component for reverse shoulderarthroplasty. Embodiments may be applied to any bone surface to includethe distal femur or proximal tibia for total knee arthroplasty, thedistal tibia or talus for ankle arthroplasty, the distal radius forfracture fixation or wrist arthroplasty, or the acetabulum for hiparthroplasty.

Embodiments may be configured for augmentation of a portion or all ofthe metaphysis of the bone, and optionally a majority thereof. Theimplant may be placed to minimize disruption of the bone in areas aroundthe implant and/or minimize disruption of the bone in areas spaced apartfrom the main functional portion of the implant, which may not have beenaccessible from the space created for the implant (such as areas foraccommodating a keel, peg, stem, or other structure of the implant). Useof bioactive materials may enhance bone structure (which may includebone matrix), allow for enhanced implant fixation, and/or beincorporated into the bone.

The methods and devices disclosed in the present disclosure may be usedin conjunction with any medical procedure on the body, for example,during intervertebral disc surgery, kyphoplasty, knee surgery, hipsurgery, organ transplant surgery, bariatric surgery, spinal surgery,anterior cruciate ligament (“ACL”) surgery, posterior cruciate ligament(“PCL”) surgery, tendon-ligament surgery, rotator cuff surgery, capsulerepair surgery, fractured bone surgery, pelvic fracture surgery,avulsion fragment surgery, shoulder surgery, hernia repair surgery,and/or surgery for an intrasubstance ligament tear, annulus fibrosis,fascia lata, flexor tendons, or any other type of medical procedure.

As additional examples, applications for embodiments may include anytype of prosthetic replacement devices that are implemented intopossibly weak and/or cancellous bone. For example, this may include hip,knee, and shoulder replacements, internal fixation devices for fracturesor fracture sequelae, suture anchors for soft tissue to bone repair, andexternal fixation devices. As a further example, embodiments may be usedfor orthopedic surgery, maxillofacial surgery, dental implants, or anyother patient tissue operation.

In the attached Figures, multiple instances of similar structures in thesame Figure have not all been labeled with element numbers, to avoidundue visual clutter and resulting confusion. One of ordinary skill inthe art will understand that, in a Figure having at least one structurecalled out with an element number, similar structures can be consideredto have the same element number.

FIG. 1 depicts a schematic side view of a patient tissue, shown here asa bone 100 (a long bone, in FIG. 1), which has a metaphysic region 102including cancellous bone and a diaphysis region 104 including corticalbone and a medullary canal.

The patient tissue is shown and described herein at least as a humerusand the prosthetic implant component is shown and described herein atleast as a prosthetic shoulder component, but the patient tissue andcorresponding prosthetic implant component could be any desired typessuch as, but not limited to, hip joints, shoulder joints, knee joints,ankle joints, phalangeal joints, metatarsal joints, spinal structures,long bones (e.g., fracture sites), or any other suitable patient tissueuse environment for the present invention.

The sequence of operations depicted in FIGS. 2-4 illustrates an exampleof a use procedure for an embodiment of the present invention. In FIG.2, the bone 100 is provided with a guide 206, which may be a stockcomponent or which may instead be a patient-specific component. In thelatter case, the guide 206 may be preoperatively designed andmanufactured in any suitable manner The guide 206 is configured to siton a desired bone 100 surface; in FIG. 2, this is the topmost bonesurface. The guide 206 includes a guide plate 208, which contacts thepatient tissue surface, and a plurality of guide tubes 210 (permanentlyattached to the guide plate or removable therefrom) which function toguide an elongate tool, such as a drill or osteotome, into theunderlying patient tissue at predetermined locations and/or depths.

FIG. 3 depicts the bone 100 after the guide 206 has been used to atleast partially dictate the location and/or depth of a plurality ofcavities 312 in the bone. The present invention is agnostic andapathetic as to the manner by which one or more cavities 312 areprovided in the patient tissue, and it will be presumed herein that anaturally occurring or at least partially manmade (e.g., hand-machinedduring the surgical procedure) cavity is present in the patient tissuewithout restriction as to its origin. For example, the cavity 312 may becreated, at least in part, by a structure of the present inventionduring operation as described herein.

In FIG. 4, a bone preparation apparatus 414 is shown mated with the bone100. The term “mate” is used herein to indicate a relationship betweentwo separate structures which are joined or fitted together closelybecause they have similar three-dimensional shapes (e.g., a positive anda negative version of the same contour, respectively). Two structures ina “mated” relationship may include at least some space therebetween, ormay even have a thin interposed structure (e.g., a cushion or membrane),but should be configured to fit substantially closely together at themated interface. The bone preparation apparatus 414 may be mated with atleast a portion of the surrounding bone 100, or these structures may bespaced apart in any desired manner, and by any desired amount. Element414 is referred to herein as a “bone preparation” apparatus, for ease ofdescription, but could be used for any reason (preparation tasks orotherwise), and in any patient tissue(s), not just bone.

The bone preparation apparatus 414 includes a manifold 416 having atleast one manifold aperture 418 extending therethrough. The manifoldaperture 418 may be selectively placed in fluid communication with afluid source (not shown), through the agency of a structure such as thefluid lines 420 shown in FIG. 4. Optionally, the fluid lines 420 may bein fluid communication with a relatively large compartment (not shown)or “tank” in the manifold, for provision of fluid to any of a number oftubes 422 which are also in fluid communication with the compartment.When this is the case, multiple fluids could be provided to thecompartment, via separate fluid lines 420, for admixture therein andsubsequent provision of a mixed fluid to the tubes 422. Alternately,each fluid line 420 may be directly connected to one or more tubes 422,with no reservoir located therebetween. As used herein, the term“manifold” is intended to mean any structure or other means which actsto direct fluid between a fluid source 434 and an insertion structure.Accordingly, a fluid line 420 could perform a “manifold” function for aparticular embodiment of the present invention and obviate the need fora separate manifold 416 structure. One of ordinary skill in the art willrealize that the fluid lines 420 and manifold 416 described herein maybe either the same or separate components, and will be able to readilyprovide fluid lines and/or manifolds for a particular application of thepresent invention.

The bone preparation apparatus 414 also includes an insertion structure(here, a plurality of tubes 422) having at least one interior cavity 424at least partially defined by a structure shell 426. The interior cavity424 of at least one insertion structure is selectively placed in fluidcommunication with a corresponding manifold aperture 418. In theembodiment of FIGS. 4 and 5, the interior cavities 424 are the lumensof, and the structure shell 426 is the tubular circumference of, theplurality of tubes 422 (“insertion structures”) shown. The tubes 422 maybe at least semi-permanently attached to the manifold 416, the bone 100and/or the fluid source, or the tubes may be temporary and readilyremovable from engagement with one or more of these other structures.

As shown in FIG. 4, the tubes 422 may be mated with the previouslyprepared cavities 312, extending into the patient tissue below/beneath(i.e., deeper than) an outer surface thereof. That is, the tubes 422 areconfigured for selective placement in a penetrating relationship with apatient tissue below (i.e., further downward on the page in theorientation of FIG. 4) the surface of the patient tissue. It iscontemplated that one insertion structure will be provided for eachcavity 312 in most embodiments of the present invention, and that thecavity will have been machined, formed, or otherwise suited to matinginsertion of a correspondingly shaped insertion structure. Here, thetubes 422 mate closely with the cavities 312 in the patient tissue, buta more general relationship in which the tube is merely inserted intosome portion of a substantially larger cavity, is also possible withoutharm to the present invention.

Optionally, and as shown in FIG. 4, when the tubes 422 are in thepenetrating relationship with the bone 100, it is possible for some bone100 or other patient tissue to be interposed laterally between any twotubes. Lateral arrow 428 shows the lateral direction in FIG. 4, whichalso extends into and out of the plane of the page.

It is contemplated that, when multiple interior cavities 424 of a bonepreparation apparatus 414 are present, at least one interior cavity mayhave a different physical configuration property (e.g., length, width,cross-sectional shape, material of the associated insertion structure,or any other physical property) from another one of the interiorcavities. As shown in FIG. 4, the plurality of tubes 422 are alldepicted schematically as having similar diameters, but have verydifferent lengths to which they extend into the bone 100. This varietyof insertion depths can be provided using various-length tubes 422and/or using same-length tubes inserted in a variable manner, todifferent depths.

At least one shell perforation 430 extends through the structure shell426 and places the interior cavity 424 in fluid communication with asurrounding ambient space, such as the patient tissue into which thecavities 312 are bored, whether or not the patient tissue forming thecavities is in direct contact with the structure shell 426. In thismanner, the tubes 422 serve as conduits or access means penetrating intothe depth of a patient tissue. It is contemplated that, when multipleshell perforations 430 are present, at least one shell perforation mayhave a different physical configuration property (e.g., length, width,perimeter shape, angle of penetration through the structure shell 426,or any other physical property) from another one of the shellperforations.

When the insertion structure (here, tubes 422) is in a penetratingrelationship, similar to that shown in FIG. 4, with a patient tissue,such as the bone 100, at least one fluid path 432 is created. The fluidpath 432 extends from a fluid source 434 of any suitable type,optionally through a manifold aperture 418 (when present), into aninterior cavity 424, through at least one shell perforation 430, andinto at least one of a proximate relationship and a contactingrelationship with the patient tissue at any suitable penetration orinsertion depth below the surface of the patient tissue. A proximaterelationship is one in which the fluid path 432 extends close to thepatient tissue. A contacting relationship is one in which the fluid path432 directly touches the patient tissue. A relationship may be bothproximate and contacting in different areas at the same time, eitherproximate or contacting but not both, or may be proximate at one timeand contacting at another time. An example of one suitable fluid path432 is shown in dashed line in FIG. 4, but one of ordinary skill in theart will be able to create any suitable fluid path using the structuresof the present invention as described herein. A myriad of fluid paths432, which may be at least partially collinear with each other or whichmay be completely separate, may extend through any bone preparationapparatus 414 in any suitable manner, and may be provided by one ofordinary skill in the art according to the teachings of the presentinvention.

Optionally, when the insertion structure (here, tubes 422) is in apenetrating relationship with the patient tissue, at least one fluidpath 432 may be substantially separated laterally (i.e., in a lateraldirection 428) from at least a portion of at least one other fluid pathby intervening patient tissue. For example, and as shown in FIG. 4,there is patient tissue located laterally between adjacent ones of thetubes 422.

A fluid may be directed along the fluid path 432 to perform a patienttissue preparation task of any desired type. That is, a fluid such as,but not limited to, a gas (e.g., nitrogen), a relatively viscous liquid(e.g., bone cement), a relatively non-viscous liquid (e.g., saline),and/or a pressure gradient (e.g., a vacuum) could be directed in eitherdirection along any one or more fluid paths 432 for any desired reasonand under any desired amount of pressure. Optionally, relatively smallparticles of solid materials may be carried by a fluid—intentionally orincidentally—without destroying the “fluid” nature of the carriermaterial. It is also contemplated that antibiotics, chemotherapy drugs,or any other fluids having therapeutic functions could be deliveredusing the fluid path 432. Any bone preparation activities provided bythe bone preparation apparatus 414 could be one-time and/or ongoing andmay occur during or after the surgical procedure in which the bonepreparation apparatus 414 is initially presented to the patient tissue.

Direction of any fluid along one or more fluid paths 432 can becontrolled in any desired manner, including manually,semi-automatically, or automatically, and using any mechanical,electronic, or any other suitable control means (e.g., valves of anytype or substantially equivalent technologies, controlled by the user inany suitable way). For example, a pump (not shown) may selectivelypasses one fluid into a selected portion of the bone preparationapparatus 414 while the same or another pump may selectively passanother type of fluid into a different part of the bone preparationapparatus. As another example, suction (i.e., a negative pressuregradient) can be selectively applied to any patient tissue(s), whetheradjacent or spaced apart from each other, using an electronicallycontrolled valve or any other means allowing suction and/or injection offluid, either singly or in an alternating manner. As an example ofoperation of the present invention, fluid, such as pressurized saline orbone cement, could be controlled to flow in a first direction (e.g.,from the fluid source toward the patient tissue) along a first fluidpath 432 and could, for instance, perform the bone preparation tasks ofrinsing and/or debriding the patient tissue (for the saline) or adheringa structure—e.g., the insertion structure—to the patient tissue (for thebone cement). A fluid—either the same or a different fluid—could becontrolled to flow along the same or a different fluid path 432 in asecond direction, which may be opposite the first direction,simultaneously or sequentially with the flow of the fluid along thefirst fluid path just described; for instance, a different fluid pathcould have a vacuum (i.e., a pressure gradient) flowing from the patienttissue toward a vacuum/fluid source, in order to suction away saline andtissue debris broken loose by the fluid flowing down the first fluidpath.

Additionally, it is contemplated that, particularly for situations inwhich fluid is flowing away from the patient tissue, through a shellperforation 430, and into the interior cavity 424, the structure shell426 may provide a “venting” function whereby the fluid is permitted toflow out of an outer surface of the insertion structure and not bedirected into the manifold. One example of this “venting” use of thebone preparation apparatus 414 is when a gas is directed from a fluidsource 434 through a first fluid path 432 toward the patient tissue todry the patient tissue proximate to and/or contacting the insertionstructure. The gas can then be “vented” through a second fluid pathwhich is open to the ambient atmosphere surrounding at least a portionof the bone preparation apparatus 414 without entering the manifold 416.As another example, a bone cement could flow along a first fluid path432 in the first direction, toward the patient tissue, at the same timethat a curing agent, such as air or another gas, flows down a secondfluid path in the first direction, the bone cement and curing agentmeeting at a location proximate or contacting the patient tissueadjacent an inserted portion of the insertion structure. One of ordinaryskill in the art can readily specify a fluid type(s), fluid source(s),flow direction(s), fluid path(s), and other desired properties for aparticular use environment of the present invention.

An alternate arrangement of the bone preparation apparatus 414 of FIG. 4is shown in FIG. 5. The bone preparation apparatus 414 of FIG. 5 depictsseveral optional features, each of which could also or instead beprovided to the bone preparation apparatus 414 of FIG. 4. Unlike thatshown in FIG. 4, the manifold 416 of FIG. 5 is recessed into a top ofthe bone 100 and is located beneath a covering plate 536, which mayassist with the fluid connections described herein, such as by linking afluid line 420 with the manifold and/or a tube 422. Each tube 422 inFIG. 5 has a 1:1 match with a corresponding fluid line 420, whilemultiple tubes 422 in FIG. 4 may share a fluid path 432 through the samefluid line 420. Additionally, the tubes 422 of FIG. 5 extend into thepatient tissue to a depth which is shown in this Figure as beingsubstantially uniform.

FIGS. 6-11 depict a bone preparation apparatus 414 and guide 206 in moredetail than that shown in FIGS. 1-5. In FIGS. 6-11, the manifold 416doubles as a guide plate 208. The manifold 416 is shown in plan view inFIG. 6, with a plurality of manifold apertures 418 present. In FIG. 7,guide tubes 210 have been inserted into some or all of the manifoldapertures 418 for a fluid connection therewith and extend from the topof the manifold 416 to form a guide 206. The same manifold 416 is shownin FIG. 8 with tubes 422 inserted into some or all of the manifoldapertures 418 for a fluid connection therewith and extending from thebottom of the manifold 416 to form a bone preparation apparatus 414. Theguide tubes 210 and/or tubes 422 may be either permanently or removablyattachable to the manifold 416—if the former, separate manifolds 416 maybe used for the guide 206 and the bone preparation apparatus 414. Formany, though not necessarily all, applications of the present invention,there will be direct correspondence between the number and locations ofguide tubes 210 or other guiding devices used to prepare the cavities312 and the number and locations of insertion structures 838, such astubes 422, inserted into the patient tissue. One of ordinary skill inthe art will realize that the manifold 416 shown in FIG. 6 need not alsohave guide plate 208 properties, however, and that separate structures(both of which may share some or all of the physical arrangement ofcomponents shown in FIG. 6) may be provided as separate guide plate andmanifold structures.

An example embodiment of an insertion structure 838 is shown in detailin FIGS. 9 and 10. The depicted insertion structure 838 is of a roundtube 422 type. The tube 422 has proximal and distal tube ends 940 and942, respectively, separated by a tube body 944 defining at least aportion of the interior cavity 424. The tube body 944 can be consideredto comprise the structure shell 426 here. The tube body 944 has at leastone tube perforation therethrough serving as a shell perforation 430.Optionally, the distal tube end 942 may be “open” to the interior cavity424 and may itself serve as a shell perforation 430.

A placement rod 946, or other relatively rigid structure correspondingphysically with at least a portion of the interior cavity 424, may beinserted into the interior cavity as shown in FIG. 9 and may be used tostiffen or reinforce the insertion structure 838 during penetration ofthe insertion structure into the patient tissue. The placement rod 946may be removed once the insertion structure 838 has achieved a desiredpenetrating, and optionally mating, relationship with the patienttissue, or the placement rod may instead be left in place and optionallyused to facilitate the creation of a desired fluid path 432.

In FIG. 10, the tube 422 has been inserted into cavity 312 in thepatient tissue 100. The cavity 312 may have been previously prepared forthe tube 422, for example, by a pre-drill procedure. In other words, thepatient tissue may be altered to accept in a mating relationship aninsertion structure 838 having a particular physical configurationproperty (e.g., length, width, cross-sectional shape, orientation withrespect to the patient tissue, or any other physical property) beforethe insertion structure is placed into the penetrating and matingrelationship with the patient tissue. Alternatively or additionally, theinsertion structure 838 itself could form at least a portion of thecavity 312 as the penetrating and mating relationship is being formed.For example, a relatively small-diameter “pilot” cavity 312 could bedrilled into the patient tissue to facilitate penetration of alarger-diameter insertion structure 838 to some extent, while theinsertion structure 838 forces the “pilot” cavity 312 to enlarge furtherduring penetration.

With particular reference to FIG. 10, the tube 422 has achieved thepenetrating and mating relationship with a bone 100 in any suitablemanner, such that the distal tube end 942 has penetrated into the boneand at least one shell perforation 430 is located beneath an outersurface 1048 of the bone. The proximal tube end 940 has been placed influid communication with a fluid source (omitted from this Figure forclarity), either directly or through connection with a chosen manifoldaperture (also omitted from this Figure for clarity). Accordingly, whenthe tube 422 type insertion structure 838 has achieved the position ofFIG. 10 and the aforementioned connections have been made, a fluid path432 extends through the manifold aperture 418, into the proximal tubeend 940, through at least a portion of the tube body 944 (serving as thestructure shell 426), through a shell perforation 430, and out of theinterior cavity 424 into at least one of a proximate and contacting(here, the latter) relationship with the patient tissue (bone 100)beneath the outer surface 1048 thereof.

FIG. 11 schematically depicts a perspective view of a bone preparationapparatus 414 having a plurality of insertion structures 838 of the tube422 type. In this Figure, the manifold 426, manifold apertures 418, andfluid lines 420 can be clearly seen. The bone preparation apparatus hasbeen inserted into a patient tissue of the bone 100 type and is readyfor use in a bone preparation operation, in which fluid flows from oneor more fluid sources 434, through corresponding fluid paths 432, andinto at least one of a proximate and a contacting relationship with aportion of the patient tissue located beneath the outer surface 1048thereof. As with any embodiment of the present invention, the structurescomprising one or more of the fluid sources 434, manifolds 426, manifoldapertures 418, fluid lines 420, and/or insertion structures 838, or anyother structures of the bone preparation apparatus 414 may be separatelyprovided from component parts attached together permanently ortemporarily, or may be monolithically formed (i.e., formed or composedof material without joints or seams) in a unitary manner from a singlepiece of raw material.

The insertion structures 838 may have any desired physical configurationproperties. With reference to FIGS. 12A-13B, the insertion structures838 may be curved tubes 422—or have any other suitable physicaldimensions/profiles—and may be made of any suitable material, includingbut not limited to any metal, porous, bioabsorbable, or biocompatablematerial. The insertion structures 838 may penetrate in any desireddirection into any portion of the patient tissue. For example, theinsertion structure 838 in FIGS. 12A and 13A is a relatively long,curved tube 422. The insertion structures 838 of FIGS. 12B and 13B aretwo somewhat shorter tubes 422 than those of FIGS. 12A and 12B, butstill have a substantially curved profile. In FIGS. 12A-13B, themanifold 416 is located atop a cut (flat) outer surface 1048 of a bone100. The bone 100 in FIGS. 12A-12B is a tibia and the bone 100 in FIGS.13A-13B is a humerus, though, as previously mentioned, the presentinvention can be used with any suitable bone or other patient tissue.

In FIG. 13A, the insertion structure 838 penetrates into the bone 100beginning at a location relatively near a laterally outer perimeter ofthe cut outer surface 1048 of the bone (e.g., into cancellous bone, theapproximate location of which is shown by the shading in this Figure, ofthe metaphysis). In FIG. 13B, the insertion structures 838 insteadpenetrate into the bone 100 beginning at locations relatively near alaterally central portion of the cut outer surface 1048 of the bone.

The insertion structures 838 may initially penetrate the bone 100 orother patient tissue at any suitable location on an outer surface 1048thereof, whether or not the outer surface has been cut or otherwisemachined during the surgical procedure. This is depicted schematicallyin FIG. 13C, in which a plurality of insertion structures 838 areschematically shown penetrating into different portions of a head of abone 100 to perform bone preparation tasks throughout that entire area.More specifically, FIG. 13C depicts a bone 100 which includes a defect1350, such as a tumor or other differentiated area of patient tissue.Optionally, defect 1350 may represent a void from which a tumor or otherpatient tissue has been removed. The bone preparation apparatus 414shown in this Figure includes a plurality of insertion structures 838,some of which extend into and/or through the defect 1350. Via the bonepreparation apparatus 414, fluid can be directed into the defect 1350volume, optionally to at least partially fill that volume (when empty),and thereby enhance the structure of the surrounding patient tissue. Themanifold 416 is optionally left in situ after conclusion of the surgicalprocedure. FIG. 13C also shows an optional fluid path 432 configuration,where multiple fluid sources 434 are provided to various of theinsertion structures 838.

FIGS. 14-15E depict additional examples of embodiments of the presentinvention in various configurations and various use environments, and atvarious points in a surgical procedure. In FIG. 14, an acetabulum 1450is depicted as including defective bone 1452 (the shaded area of FIG.14). A prosthetic implant component 1454 (here, an acetabular cup) hasbeen placed as desired and the defective bone 1452 was be backfilled(e.g., injected) with bone graft substitute, bone cement, and/or growthpromoting material, or any other desired material, through use of thebone preparation apparatus 414. Additionally or alternately, theprosthetic implant component 1454 can be attached to the patient tissuethrough the use of a fluid provided by the same, or a different, bonepreparation apparatus 414. Here, a bone preparation apparatus 414 hasbeen used in a similar manner to that shown in FIGS. 1-4. The manifold416 has been removed from the surgical site already in this view, andthe tubes 422 are remaining at least semi-permanently inserted into thebone 100 at or near the site of the defective bone 1452. A cover plate536 may be present (attached to or separate from the prosthetic implantcomponent 1454) to act as a buttress plate and prevent the bone graftsubstitute, bone cement, and/or growth promoting material, or any otherdesired material from oozing out of the cavity 312 around the prostheticimplant component 1454. In this way, it is demonstrated that cancellousbone that is otherwise intact can be reinforced to support a graft orimplant that is otherwise used to reconstruct the defect and/or jointsurface, either by directly replacing or augmenting a native(potentially defective) structure.

FIG. 15A is similar to FIG. 14 in that a bone 100 (here, a tibia) has anarea of defective bone 1452 which has been adjusted or reconfiguredusing a bone preparation apparatus 414. However, in FIG. 15A, the coverplate 536 is attached to, or part of, the prosthetic implant component1454 (here, a tibia plate). Here, the tubes 422 are remaining in apenetrating relationship into the patient tissue adjacent the defectivebone 1452, and fluid provided to the area of the defective bone 1452 hasflowed along a fluid path 432 through the tubes 422 and into otherportions of the bone 100.

FIG. 15B depicts a similar arrangement to that of FIG. 15A, with aslightly different arrangement for the cover plate 536 portion of theprosthetic implant component 1454. Likewise, FIGS. 15C-15E depictadditional arrangements of previously emplaced and utilized componentsof a bone preparation apparatus 414, similar to of the final arrangementshown in FIG. 15A. In FIGS. 15C-15D, the tubes 422 extend through theprosthetic implant component 1454 and through the defective bone 1452area, into another portion of the bone 100, with the insertionstructures 838 extending through the defective bone 1452 area (whichcould have previously been at least partially filled with bone graftmaterial). In FIG. 15E, the defective bone 1452 area itself has beenexcised and filled with a prosthetic implant component 1454, from whichthe tubes 422 or other insertion structures 838 extend into otherportions of the bone 100. FIGS. 16-19 depict a bone preparationapparatus 414′ according to a second embodiment of the presentinvention. The bone preparation apparatus 414′ of FIGS. 16-19 is similarto the bone preparation apparatus 414 of FIGS. 1-15E and therefore,structures of FIGS. 16-19 that are the same as or similar to thosedescribed with reference to FIGS. 1-15E have the same reference numberswith the addition of a “prime” mark. Description of common elements andoperation similar to those in the previously described first embodimentwill not be repeated with respect to the second embodiment.

In the embodiment shown in FIGS. 16-19, a broach 1656, for example, ahollow shell broach, is depicted. Broach 1656 may have a hollow interior1758. Broach 1656 may have shell perforations 430′ on its outer surfaceand/or a solid center core 1760. Broach 1656 may be placed into a bone100, for example, a long bone in which the metaphysis requiresenhancement. The broach 1656 may be configured for engagement with afluid source (not shown) via manifold 416′ and/or may be directlyattachable to the fluid source. The broach may be connectable to abroach impactor (not shown) through broach hole 1762, which may includea taper. The broach impactor may be used to position broach 1656.

By connecting broach 1656 to a fluid source, broach 1656 may serve as atleast an insertion structure 838′ of a bone preparation apparatus 414′and thereby perform at least one bone preparation task in a surgicalenvironment. Broach 1656 may be positioned in bone 100, for example, ina cavity 312′ of an intramedullary canal of a tibia or femur. Broach1656 may be connected to a fluid source, optionally via a manifold (notshown), through use of a taper (i.e. Morse taper), screw, thread,locking mechanism, slip fit, interference fit, press fit, adhesive,bondable material, any combination thereof, or any other suitableconnecting means. The fluid source may apply suction (i.e., a negativepressure gradient) to broach 1656 to remove excess or unwanted tissueand materials from the cavity 312′. Additionally, the fluid source mayinject (i.e., with a positive pressure gradient) fixation material,therapeutic substance, or any other fluid into the cavity 312′ via afluid path (e.g., 432′) extending through the broach 1656.

Broach 1656 may be removable after its use for bone preparation is over,or may be left in position for use as a semi-permanent final prostheticimplant component 1454′. (“Semi-permanent” is used herein to indicatethat such a structure remains in the patient tissue after conclusion ofthe surgical procedure, regardless of how long such maintenance isintended to last and whether or not the structure was originallydesigned for such maintenance. Some examples of semi-permanentstructures include replacement/artificial joint components andresurfacing joint components, whether trials for temporary use by thepatient or intended to last some portion or all of the rest of thepatient's life.)

That is, when the broach 1656 is acting as a removable component of abone preparation apparatus 414′, the insertion structure 838′ of thebroach is temporarily placed into a penetrating relationship below theouter surface 1048 of the patient tissue during the surgical procedureand is removed from the penetrating relationship before the surgicalprocedure ends. When the broach 1656 is serving as a temporary bonepreparation tool and later removed, a standard prosthetic implantcomponent (not shown) can be placed in the space of the patient tissuevacated by the removed broach. Alternatively, another permanent bonepreparation apparatus 414 (as shown in FIG. 21-32 or 42A-45 anddiscussed below) can be inserted as an at least semi-permanent devicehaving the capacity for additional bone preparation functions, which maybe similar to those discussed above with reference to FIGS. 1-5.

Conversely, when the broach 1656 is acting as at least a portion of asemi-permanent final prosthetic implant component 1454′, the insertionstructure 838′ of the broach is at least semi-permanently placed into apenetrating relationship below the outer surface 1048 of the patienttissue during the surgical procedure and remains in the penetratingrelationship after the surgical procedure ends. These removable andsemi-permanent characteristics/properties apply where appropriate forany embodiment of the present invention, not just the broach 1656 of thesecond embodiment. If broach 1656 is configured as at least a portion ofa final prosthetic implant component 1454′, broach is optionallyconnectable to an arthroplasty component.

As an example of a semi-permanent use of a bone preparation apparatus414 in a short- or medium-term patient use (whether or not intended fora limited time), a revision procedure may be required at some time afterthe initial surgical procedure, for example, when broach 1656 is used asa final prosthetic implant component 1454′. The arthroplasty component(not shown) attached to the broach 1454′ may be removed and/or the fluidsource (not shown) may be reconnected to the broach 1656, with orwithout an intervening manifold. By reconnecting the fluid source,suction may be applied to the patient tissue 100 proximate or contactingthe outer surface of the broach 1656 to remove excess or unwanted tissueand other debris/materials. Additionally, a fixation material,therapeutic substance, and/or other fluid may be provided to the patienttissue via the previously implanted broach 1656 as an insertionstructure 838. A new, or the same, arthroplasty component may bereconnected to the broach 1656 at the end of the revision procedure.

Bone preparation and enhancement may also be performed using broaches,trial implants, or final implants as insertion structures 838′.Referring to FIGS. 20A and 20B, a typical long bone 100 includes acortical diaphysis (lower region shown), cancellous metaphysis (middleregion shown) and epiphysis (upper region shown). FIG. 20B shows thebone 100 after removal of the epiphysis (e.g., a humeral head) from thebone version depicted in FIG. 20A.

FIGS. 21-25 depict a bone preparation apparatus 414″ according to athird embodiment of the present invention. The bone preparationapparatus 414″ of FIGS. 21-25 is similar to the bone preparationapparatus 414 of FIGS. 1-15E and therefore, structures of FIGS. 21-25that are the same as or similar to those described with reference toFIGS. 1-15E have the same reference numbers with the addition of adouble “prime” mark. Description of common elements and operationsimilar to those in the previously described first embodiment will notbe repeated with respect to the third embodiment.

Referring to FIGS. 21-25, embodiments may include a series of perforatedtubes or plates as a trial prosthetic implant component 1454″, broach1656″, or other tool (hereafter all presumed to be covered by the term“prosthetic implant component”), or as a final prosthetic implantcomponent 1454″. A “trial” prosthetic implant component 1454″ isconfigured to be placed temporarily and then removed before the end of asurgical procedure. A “final” prosthetic implant component 1454″ isconfigured to be left in the patient at least semi-permanently aftercompletion of a surgical procedure. The trial or final prostheticimplant component 1454″ may include at least one shell perforation 430″.The trial or final prosthetic implant component 1454″ may be at leastpartially embeddable into a patient tissue (e.g., bone 100″ tissue suchas cancellous bone). The trial or final prosthetic implant component1454″ may be configured to serve as all or part of a bone preparationapparatus 414″, and as such, may be connectable to a fluid source 434″for creation of a fluid path 432″ between the fluid source and a patienttissue.

For example, the prosthetic implant component 1454″ shown in FIG. 21includes an insertion structure 838″ having a partisphericalconfiguration. The depicted prosthetic implant component 1454″ may beinserted into a cut outer surface 1048″ of a humerus, as shownschematically in plan view in FIG. 22 and in side view in FIG. 23.Optionally, the outer surface 1048″ of the humerus may have beenmachined (e.g., using a partispherical reamer, not shown) to include acavity 312″ for accepting the prosthetic implant component 1454″,serving here as a bone preparation apparatus 414″, in a mating andpenetrating relationship.

FIGS. 24 and 25 depict bottom views of example manifolds 416″ which canbe associated with the prosthetic implant component 1454″ to form a bonepreparation apparatus 414″. In FIG. 24, the manifold 416″ includes acentral aperture 2464 for connection to a fluid source 434″ (directly orthrough one or more fluid lines 420″). The central aperture 2464 thendirects fluid to the manifold apertures 418″ through an internalmanifold channel 2466 (here, an asterisk-shaped construct). In FIG. 25,the internal manifold channel 2466 has a linear profile.

FIGS. 26-30 depict a bone preparation apparatus 414′″ according to afourth embodiment of the present invention. The bone preparationapparatus 414′″ of FIGS. 26-30 is similar to the bone preparationapparatus 414 of FIGS. 1-15E and therefore, structures of FIGS. 26-30that are the same as or similar to those described with reference toFIGS. 1-15E have the same reference numbers with the addition of atriple “prime” mark. Description of common elements and operationsimilar to those in the previously described first embodiment will notbe repeated with respect to the fourth embodiment.

Optionally, the insertion structure 838′″ may include multiplecomponents or subassemblies which can themselves be inserted into apenetrating, and optionally mating, relationship with a cavity 312′″ ina patient tissue. FIGS. 26-29 depict a tibial bone 100′″ useenvironment, with a humeral use environment shown in FIG. 30, for a bonepreparation apparatus 414′″ according to the fourth embodiment of thepresent invention. As shown in these Figures, the bone preparationapparatus 414′″ has an insertion structure 838′″ comprising an insertioncore 2768 and one or more (three shown) insertion fins 2770; theinsertion core and/or insertion fins may be provided as a part of theinsertion structure or may be separately provided. Optionally, theinsertion fins 2770 may be attached to an insertion collar 2772 forconnection to the insertion core 2768 and/or a manifold 416′″ or othermeans of conveying fluid from a fluid source 434′″ to the shellperforations 430′″. In FIGS. 26-29, this attachment is made via athreaded, screw-type connection. However, the insertion fins 2770 andinsertion core 2768 may have any suitable attachment mechanism—or noneat all, when these components are not attached together—and may bereadily provided by one of ordinary skill in the art for a particularapplication of the present invention.

Optionally, and as shown in FIG. 29, the insertion core 2768 may includea hollow stem which acts as an interior cavity 424′″. Using a hollowinsertion core 2768, a variety of fluid paths 432′″ can be created toallow fluid access to/from many different areas of the cavity312′″/312A′″ and the patient tissue near the bone preparation apparatus414′″. The hollow stem or any other interior cavity 424′″ may be filledwith any desired substance (e.g., bone cement, metal rod, or any othersuitable filler) after the bone preparations tasks have been completed.A filled stem or other interior cavity 424′″ may be helpful in providingstructural stability, for example, when the insertion structure 838′″ isleft at least semi-permanently within the patient tissue.

As shown in FIGS. 27-28, a shaped cavity 312′″ may be provided toclosely accept the insertion structure 838′″ in a relatively closemating relationship. Alternatively, a more generically configured cavity312A′″ (shown in dashed line in FIG. 28) may be created to accept theinsertion structure 838′″ in a less-close mating relationship. Anydesired material may be provided—though is not necessarily present—inany suitable manner to fill the portions of the generic cavity 312A′″which are not occupied by the insertion structure 838′″.

In the embodiment of the bone preparation apparatus 414′″ shown in FIGS.27-28, the insertion structure(s) 838′″ may be placed into a penetratingrelationship with the patient tissue by being inserted into a preparedcavity 312′″ of any desired shape. Alternatively or additionally, atleast a portion of the insertion structure(s) 838′″ may be inserted intothe patient tissue with no prepared cavity 312′″, such that theinsertion structure 838′″ forms its own cavity as it enters the patienttissue under some amount of force.

A broach (not shown), other tools, or a trial or final prostheticimplant component 1454′″ can be used to provide one or more fluid paths432′″ into a cavity 312′″ in the patient tissue. The fluid path(s) 432′″can then be used to direct any desired flowable substance into thecavity 312′″, optionally to help with fixation of the prosthetic implantcomponent 1454′″ in the patient tissue. For example, bone cement can bedirected along the flow path within the bone preparation apparatus 414′″and into at least a portion of the surrounding cavity 312′″. Optionally,the bone cement can be provided under sufficient pressure to penetratesome distance into the patient tissue surrounding the bone preparationapparatus 414′″.

Particularly when the bone preparation apparatus 414′″ doubles as aportion of a prosthetic implant component 1454′″, the bone preparationapparatus can be held in place while the bone cement flows therethroughand cures, such that the bone cement functions to adhere the bonepreparation apparatus in place mechanically and/or chemically.Alternatively, the bone preparation apparatus 414′″ may be at leastpartially removed from the patient tissue once the fluid (e.g., bonecement) has been provided within the cavity 312′″ and a prostheticimplant component 1454′″ may be inserted in place of the bonepreparation apparatus for affixation by the previously placed bonecement.

Alternatively, the cavity 312′″, possibly with fluid contained therein,could be left unfilled to close naturally or could be closed by asurgeon with no structure (such as an implant or tool) located therein.Optionally, an insertion structure 838′″ which has been cemented intoplace can be used as a base or anchor for attachment to a separatelyprovided portion of a prosthetic implant component 1454′″, as shown inFIGS. 29-30.

The above example uses affixation of a prosthetic implant component1454′″ to a cavity 312′″ using bone cement as a fluid, but any desiredbone preparation task(s) can be carried out during/after a surgicalprocedure, using any desired fluid(s), for any reason. As anotherexample of a suitable bone preparation task, the bone preparationapparatus 414′″ may be used to provide pressurized saline to a cavity312′″ and may also be used to simultaneously or sequentially supply asuction pressure gradient to remove the saline and included patienttissue debris from the cavity 312′″.

FIG. 30 shows a bone preparation apparatus 414′″ similar to that ofFIGS. 26-29, except that the bone preparation apparatus of FIG. 30 isused with a humeral prosthetic implant component 1454′″, rather than thetibial prosthetic implant component of FIGS. 26-29.

FIGS. 31-32 depict a bone preparation apparatus 414 ^(iv) according to afifth embodiment of the present invention. The bone preparationapparatus 414 ^(iv) of FIGS. 31-32 is similar to the bone preparationapparatus 414 of FIGS. 1-15E and therefore, structures of FIGS. 31-32that are the same as or similar to those described with reference toFIGS. 1-15E have the same reference numbers with the addition of a Romannumeral “iv” superscript. Description of common elements and operationsimilar to those in the previously described first embodiment will notbe repeated with respect to the fifth embodiment.

FIG. 31 depicts a plurality of bone preparation apparatus 414 ^(iv)which can be used as anchors within the bone 100 ^(iv) or other patienttissue. For example, one or more bone plates 3174 can be attached to thebone 100 ^(iv) using an inserted screw 3176 having bone preparationapparatus 414 ^(iv) features. The screw 3176A is attached to a remotelylocated fluid source 434 ^(iv) by a fluid line 420 ^(iv), optionallythrough a remotely located manifold (416 ^(iv), omitted from thisFigure). The screw 3176B is directly connected to a proximate fluidsource 434 ^(iv) that is secured to, and steadied with, the bone plate3174 by use of seal 3178—for example, the proximate fluid source 434^(iv) may be a flexible reservoir that is squeezed to direct fluidthrough fluid line 420 ^(iv) and into the interior cavity 424 ^(iv) ofthe insertion structure 838 ^(iv). The screw 3176C is driven into thebone 100 ^(iv) using a driver 3180, which may have a cannulated shaft3182. Optionally, a fluid source 434 ^(iv) may be placed in fluidcommunication with the cannulated shaft 3182 to direct fluidtherethrough—thus using the cannulated shaft as a fluid line 420^(iv)—and into the screw 3176C for provision to the associated cavity312 ^(iv).

FIG. 32 depicts an insertion structure 838 ^(iv) which takes the form ofa suture anchor. The suture anchor type insertion structure 838 ^(iv)may include a thread, cannulation, and/or perforation, any of which maybe configured for use as a shell perforation 430 ^(iv) to help provide afluid path 434 ^(iv) for provision of fluid from a fluid source 434^(iv) to patient tissue, such as cancellous bone surrounding theinsertion structure 838 ^(iv). For example, bone cement could be pumpedinto the bone 100 ^(iv) to assist with affixation of the suture anchorand thereby help resist pullout of the suture anchor under force from anattached suture thread 3184.

Embodiments of the present invention may include devices and instrumentsfor implantation and/or application-specific preparation of the patienttissue site. Embodiments may include suction and/or irrigation forpartial or complete removal of the marrow contents, which may includeareas adjacent to the prosthetic implant component 1454. The applicationof fixation material or any other fluid used with a bone preparationapparatus 414 may be selected based on the area of the body, thepatient's treatment site, the type of the prosthetic implant component1454 to be used, or any other desired selection factors. This allowsselection of an appropriate prosthetic implant component 1454 and/ormethod to fit the patient conditions and/or type of procedure, forexample, based on bone condition, condition of a joint replacement, typeof fracture fixation, type of reconstruction, or any other patienttissue condition(s).

FIGS. 33A-45 depict an example embodiment of a bone preparationapparatus 414 according to any embodiment of the present invention,along with multiple tools, devices, instruments, and the like which canbe used for application-specific preparation of the patient tissue andimplantation of a trial or final prosthetic implant component 1454, ofwhich the bone preparation apparatus 414 comprises a portion.

In FIGS. 33A-45, patient tissue, such as cancellous or another type ofbone 100 may be prepared by using a custom or stock cutting tool,osteotome, and/or power burr to create a cavity 312 in the boneconfigured for the shape and/or dimensions of a bone preparationapparatus 414, for example, a suction, irrigation and/or injection bonepreparation apparatus. A pin guide 3386, such as that shown in FIGS.33A-33B, can be used to help set a guide pin 3388 into underlying bone100—here, a convex portion of a humeral head shown schematically—at apredetermined location and trajectory. Once placed, the guide pin 3388can remain in the bone 100 to help guide the user in later steps of thesurgical procedure.

FIG. 34 shows a manual reamer 3490 which is cannulated to fit over theguide pin 3388 and be guided thereby into machining contact with thebone 100. The manual reamer 3490 is used to flatten an outer surface1048 of the bone 100 into the shape shown schematically in FIG. 34, andthen the manual reamer is removed from the surgical site while the guidepin 3388 remains.

In FIG. 35, a cannulated central drill 3592 is optionally guided towardthe bone 100 (specifically, the flatted outer surface 1048 thereof) todrill a guide hole 3694 in the bone. Once the guide hole 3694 isdrilled, a plug 3696 may be placed into the hole to help guide latersteps of the surgical procedure with a more robust anchored structure(i.e., the plug) than the guide pin 3388 provides. The guide pin 3388may remain in the bone 100, as shown in FIG. 36, along with the plug3696, if desired. Alternately, the guide pin 3388 itself may do all ofthe guiding functions without the guide hole 3694 and plug 3696.

FIGS. 37A-37C show a box osteotome 3798 which has a plurality of fincutters 37100 to help create a cavity 312 having a cruciform profile.The box osteotome 3798 is cannulated and is slid over the guide pin3388, until reaching a “hard stop” engagement with the plug 3696, in thearrangement shown in FIG. 37C.

FIGS. 38A-38C depict an alternate arrangement of a box osteotome 3798A,which incorporates a plug feature—for this embodiment, the plug 3696 isomitted (though the guide hole 3694 may still be present) and the boxosteotome is guided into the bone 100 to create the cavity 312, as shownin FIG. 38C, through sliding engagement with the guide pin 3388.

An eight-blade osteotome 39102 is shown in FIGS. 39A-39B. Similar to thebox osteotome 3798, the eight-blade osteotome 39102 is guided intocutting contact with the bone by the guide pin 3388. This cuttingcontact should be oriented so that the cutter blades 39104 of theeight-blade osteotome penetrate into the portions of the bone 100 whichhave already been cut into and weakened by the fin cutters 37100 of thebox osteotome 3798. The cutter blades 39104 will help morselize the bone100 or other patient tissue in those previously weakened areas forsharper definition of the edges of the cavity 312 and easier removal ofthe patient tissue debris from the cavity. The straight osteotome 40106and/or curved osteotome 40108, shown in FIGS. 40A and 40B, respectively,can be used in a known manner to further clean up and define the edgesof the cavity 318.

FIG. 41 depicts a trial prosthetic implant impactor 41110. The impactor41110 has a plurality of impactor fins 41112 which each correspond to anarea of the cavity 312 where the bone was removed by a fin cutter 37100and/or a cutter blade 39104. The surgeon can place the impactor 41110into the cavity 312 and exert a steady and/or percussive force on theflat upper stem of the impactor to drive the impactor fins 41112 furtherinto the cavity 312 and thereby even further clean up and define theedges of the cavity 318.

After use of the impactor 41110 and the example other tools shown inFIGS. 33A-41, or any other suitable tools, the cavity 312 will achieve acruciform cross-sectional shape which is a concave or “negative” versionof the convex or “positive” shape created by the impactor fins 41112such that the impactor 41110 will mate into the cavity 312 reasonablyclosely. Alternately, the cavity 312 may be natively present and/or maybe machined/formed in any suitable manner, whether or not the finalshape of the cavity is configured to mate with a tool, a trial or finalprosthetic implant component 1454 or any other structure.

Turning to FIGS. 42A-42B, a prosthetic implant component 1454 is shown.While the depicted prosthetic implant component 1454 is a finalcomponent, configured to remain engaged with the patient tissue at leastsemi-permanently, a trial component could be provided and used in asimilar manner to that described and depicted herein. The prostheticimplant component 1454 of FIGS. 42A-42B has a central bore 42114defining an interior cavity 424A which is not in fluid communicationwith the interior cavities 424B of the fins 42116. (A majority of theprosthetic implant component 1454 structure forms the insertionstructure 838.)

The cross-sectional view of FIG. 42B shows the structure of theprosthetic implant component 1454 and the portions of the prostheticimplant component which function as structures of the bone preparationapparatus 414. An example fluid path 432 is shown extending into aninterior cavity 424B of a fin 42116 of the prosthetic implant component1454 and out through a chosen shell perforation 430 for provision anddirection of fluid outside the insertion structure 838 to the patienttissue and/or the space within the cavity 312. As can be seen in FIG.42B, the structure shell 426 is relatively thin-walled, such that ahigher percentage of the total volume of the prosthetic implantcomponent 1454 may be dedicated to interior cavity 424 space than isprovided/filled by the structure shell. The interior cavity 424A of thecentral bore 42114 is configured for fluid communication with a manifold416, as will be discussed below.

FIGS. 43A-43B depict an alternate embodiment of the prosthetic implantcomponent 1454A which is substantially similar to the prosthetic implantcomponent 1454 of FIGS. 42A-42B. However, in FIGS. 43A-43B, theprosthetic implant component 1454A includes a cover plate 536 and aplate protrusion 43118, the latter in fluid communication with theinterior cavity 424A of the central bore 42114. The cover plate 536and/or plate protrusion 43118 shown in FIGS. 43A-43B may help to engagea manifold 416 in fluid communication with the interior cavities 424 ina slightly different way than that of the prosthetic implant component1454 of FIGS. 42A-42B.

FIG. 44A depicts a bone preparation apparatus 414 having a prostheticimplant component 1454 (such as that depicted in FIGS. 42A-42B) servingas an insertion structure 838 and having a manifold 416 attachedthereto. As shown by the example fluid path 432, any of the manifoldapertures 418 can be placed into fluid communication with any of theinterior cavities 424 and any of the shell perforations 430; one ofordinary skill in the art can readily provide a manifold 416 andcorresponding insertion structure 838 having desired fluid path 432properties for a particular application of the present invention.

FIG. 44B is a cross-sectional view of the bone preparation apparatus 414shown in FIG. 44A, with additional detail showing the interiorstructures of the manifold 416. Here, one fluid path 432A extendsthrough a first manifold aperture 418A for provision of a first fluid tothe interior cavity 424A of the central bore 42114. A second fluid path432B extends through a second manifold aperture 418B for provision of asecond fluid (which may differ from the first fluid) to the interiorcavity 424B of at least one fin 42116. The fluids may flow in the samedirection or opposite directions along the first and second fluid paths432A and 432B. The fluid(s) may be provided by one or more fluid sources434, connected in any suitable manner to the manifold 416.

FIG. 44C is a cross-sectional view of a portion of the manifold 416 thatshows the locations of the different manifold apertures 418A and 418Bwithin the body of the manifold. Similarly, FIG. 44D is a partiallytransparent view of a manifold 416 that shows fluid paths 432A, 432B,and 432B′ corresponding to manifold apertures 418A, 418B, and 418B′,respectively. Using a manifold 416 similar to that shown in FIG. 44D,three different fluids can be provided to the insertion structure ofFIGS. 42A-42B, as desired by the surgeon.

FIG. 45 shows an exploded view of an alternate means of providing fluidto one or more fins 42116. In FIG. 45, a relatively simple and compactmanifold 416 (when compared to the manifold of FIGS. 44A-44C),configured to mate with an interior cavity 424 of a chosen one of thefins 42116, may be placed individually into contact with any or all ofthe fins of a particular insertion structure 838 (here, the fins arepart of a prosthetic implant component 1454). A fluid path 432 can becreated and a fluid provided at least one of proximate and contacting apatient tissue beneath an outer surface thereof.

The bone preparation apparatus 414 may be configured to the shape and/ordimensions of the cavity 312, or vice versa. The bone preparationapparatus 414 may be a template, configurable to the size of theimplant, and/or may itself be implantable. The bone preparationapparatus 414 may be cannulated and/or include one or more shellperforations 430 along its surface to allow for suction, irrigation,and/or injection of fixation and/or bone enhancement materials, or anyother suitable materials. The bone preparation apparatus 414 (whether ornot it also includes structures functioning as a prosthetic implantcomponent 1454) may allow for preparation of the bone marrow spaceadjacent to the bone preparation apparatus, removal of the marrowelements, and/or creation of a cavity 312 in the patient tissue adjacentto and/or approximately sized to the insertion structures 838 of thebone preparation apparatus 414.

Embodiments may include the injection of fixation material, for example,in a liquid or semi-liquid state. The fixation material(s) may beinjected into a bone preparation apparatus 414 serving as a trial ortemplate of a final prosthetic implant component 1454. The addedfixation materials may be dispersed using a fluid source 434, forexample, that used with the bone preparation apparatus 414. The bonepreparation apparatus 414 may include part of the final prostheticimplant component 1454. The fixation materials may be placed adjacent tothe prosthetic implant component 1454 to reinforce the bone, preferablyin the area to be used for implant fixation. Embodiments may allowfixation materials to be placed in areas not easily accessible usingtraditional methods. Embodiments may allow for preservation of the bonestructure, marrow, and/or other tissue elements. Bone or other patienttissue spaced apart from the bone preparation apparatus 414 may be keptintact and/or may be prepared and augmented with standard bonepreparation methods.

The bone preparation apparatus 414 may be made of any material mentionedin the present disclosure or known in the art. The bone preparationapparatus 414 may be made of a reusable or disposable material.Embodiments may first perform suction and/or irrigation to prepare thebone, and then add the bone filler or PMMA cement to the prepared bone.Embodiments may be impacted using a tamp or series of tamps that haveand maintain the shape of the bone preparation apparatus 414 and/or theprosthetic implant component 1454.

Embodiments of the present disclosure may relate to bone preparationinstruments and/or implants. A device may be attached to an instrumentor implant to provide suction, irrigation or injection of materialthrough the instrument or device into the surrounding cancellous bone.Embodiments may increase or decrease fixation, for example, by includingperforations, slots, bumps, textures, or other features for facilitatingfixation with bone. Such features may allow for preparation of the bone,addition of materials, and/or stabilization of an implant. Embodimentsmay be configured for use with instruments, trials, temporary implants,permanent implants, broaches, and any other device suitable for usewithin a body. For example, embodiments may be used for orthopedicsurgery, hip, knee and shoulder replacements, maxillofacial surgery,dental implants, internal fixation devices for fractures or fracturesequelae, suture anchors for soft tissue to bone repair, and externalfixation devices. The implant or instrument provides a mechanism formodification of the bone through the instrument or implant.Additionally, embodiments may be configured to adjust and/or enhance thefixation of the implant, for example, to bone, soft tissue, and/oranother implant.

Embodiments may be positioned a distance from a prepared bone surfaceand/or utilized for setting weakened and/or cancellous bone. Exampleembodiments may be dimensioned and configured for preparing bone,providing irrigation, providing suction, providing growth promotingmaterials, and/or providing materials for hemostasis. Embodiments may beconfigured to remove materials (e.g., marrow, tissue, unwantedmaterials, any material mentioned in the present disclosure or known inthe art, or any combination thereof) and/or to add materials (e.g.,synthetic materials, biologic materials, matrix, cells or growthfactors, fixation materials, therapeutic substances, any other materialmentioned in the present disclosure or known in the art, or anycombination thereof).

Additionally, embodiments may be positioned with respect to an implant,for example in an area adjacent to the implant. Embodiments may beconfigured to allow for placement of bone cement, bone graft materials,bone graft substitute material, synthetic materials, biologic materials,non-biologic materials, and/or any material mentioned in the presentdisclosure or known in the art or any combination thereof. Embodimentsmay improve the immediate-, short-, and/or long-term fixation of theimplant, for example, by enhancing the structure of the bone adjacent tothe implant.

Additional embodiments may be configured to place materials at theprosthetic-bone interface. Materials may be placed over the entiresurface or confined to selected areas. Materials may be applied whilethe device is in situ to enhance the fixation and/or allow for theuniform and/or direct addition of materials at the prosthetic-boneinterface.

Embodiments may be any material suitable for use in the body, forexample, porous, natural, and/or absorbable materials. Embodiments maybe patient-specific to the patient's dimensions and/or the surgicalsite. Embodiments may include metals, polymers, or any otherbiocompatible material. Embodiments may include smooth, roughened,and/or porous surfaces. Embodiments may be formed with cavities or othershapes. Embodiments may include stainless steel, shape memory alloys(e.g., Nitinol), tantalum, porous tantalum, titanium, cobalt-chromealloys, and/or any other material mentioned in the present disclosure orknown in the art or any combination thereof.

Embodiments may include a screw, intermedullary rod, plate, externalfixation pin, stem, suture anchor, and/or fixation devices or mechanismsto secure an implant to patient tissue and/or to another implant—forexample, securing a prosthetic to bone. An embodiment may include acentral void, potentially with perforations along a portion of or itsentire surface. The perforations, when present may be configured for thesuction, injection, and/or irrigation of the bone material adjacent tothe implant and/or injection of a filler material (e.g., bone graftmaterial, bone graft substitutes, hemostatic agents [pharmacologic orphysical materials], growth factors, biologic materials, cells with orwithout a matrix scaffold, and/or any material mentioned in the presentdisclosure or known in the art or any combination thereof).

Additional embodiments may include application in the spine,extremities, axial skeleton, craniofacial, or any other suitable bones.Embodiments may be applied in fracture reconstruction, primary orrevision joint replacement, traumatic and arthritic conditions, tumorreconstruction, soft tissue to bone repair, in conjunction with sutureanchors, and/or for management of pediatric bone lesions. Embodimentsmay be used for bone preparation, bone augmentation, and/or implants.Embodiments may improve immediate and/or long-term fixation of animplant.

Embodiments may at least partially include, and/or be positioned,attached, and/or stabilized relative to each other or relative to aportion of a body of a patient and/or another implant using, any one ormore of the following materials and/or configurations, or any othersuitable material and/or physical treatment or property:polymethylmethacrylate (“PMMA”); bone cement; glue; adhesive (e.g., boneadhesive); grouting agents; bone graft substitute; injectable materials;synthetic materials; natural materials; acrylics; materials that arebondable, biocompatible, degradable, biodegradable, bioerodible,bioabsorbable, mechanically expandable, hydrophilic, bendable,deformable, and/or malleable; and connections and/or components that areriveted, threaded, toggling, barbed, bubbled, laminated, coated,blocking, pneumatic, one-piece, multi-component, solid, hollow,polygon-shaped, pointed, and/or self-introducing. Also, embodiments mayinclude, but are not limited to, being comprised partially or entirelyof a metallic material, polymeric material, ceramic material, compositematerial, body tissue from any source, synthetic tissue, hydrophilicmaterial, expandable material, compressible material, bondable material,and/or any material disclosed in the present disclosure or known in theart or any combination thereof.

Further embodiments may be configured to include other parts of anysuitable fixation mechanism—for example, by connecting component partsto standard and/or traditional parts of a final or trial implant.Embodiments may be connectable through a taper (e.g., Morse taper),screw, thread, locking mechanism, slip fit, interference fit, press fit,adhesive, bondable material, and/or any material mentioned in thepresent disclosure or known in the art or any combination thereof.

Fixation of a prosthetic implant component 1454 may be enhanced usingthe disclosed bone preparation apparatus 414 with the aid of a fixationmaterial (e.g., a bone filler, bone graft substitute, and/or bonecement). The fixation material may be placed relative to the bone, then,the fixation material may be impacted. Preferably, the fixation materialshould reach the marrow space of a bone for some use environments of thepresent invention. Pulsatile irrigation may be used, with or without abone preparation apparatus 414, to remove a portion or all of the marrowelements before placement of the fixation material, which may facilitatepenetration of the fixation material into the bone surface. After atleast a portion of the fixation material has been added, the implant maybe placed into position. Irrigation and/or the addition of fixationmaterial may be achieved with a typical or stock instrument, which neednot be specific to the implant size, shape or location of the implant,or may be accomplished with the help of the disclosed bone preparationapparatus 414.

Bone preparation may also be performed with non-biologic material, suchas glue, PMMA, or a bioabsorbable bone graft substitute or biologicmaterial consisting or cells, matrix carrier, bioactive molecules,and/or any material mentioned in the present disclosure or known in theart or some combination thereof.

Embodiments may include therapeutic substances—for example, antibiotics,hydroxyapatite, anti-inflammatory agents, steroids, antibiotics,analgesic agents, chemotherapeutic agents, bone morphogenic protein(“BMP”), demineralized bone matrix, collagen, growth factors, autogenicbone marrow, progenitor cells, calcium sulfate, immunosuppressants,fibrin, osteoinductive materials, apatite compositions, germicides,fetal cells, stem cells, enzymes, proteins, hormones, cell therapysubstances, gene therapy substances, and/or any material mentioned inthe present disclosure or known in the art or any combination thereof.These therapeutic substances may be combined with the materials used tomake the device or may be separately provided.

Embodiments may include one or more tubes, pylons, ducts, channels,conduits, cannulations, or the like (referred to throughout as “tubes”),which may include one or more perforations, fenestrations, apertures,punctures, or the like (referred to throughout as “perforations”).Embodiments may include tools and/or instruments, which may includereusable, absorbable, and/or synthetic materials that may remain in situor be removed. For example, an injection tool may be inserted,potentially relative to or into pre-drilled holes.

Embodiments may include a pressure instrument, for example, any suction,irrigation, injection, pump, infusion, pneumatic, or compression device,or any device capable of creating positive or negative pressure. Thepressure instrument may be attachable to any or all the tubes. Thepressure instrument may include a cannulated manifold for suction and/orirrigation of bone and/or the addition of materials to the surroundingtissue and/or bone matrix. In this embodiment, the implant and/or toolmay remain in position if made of a resorbable material, or, if removed,holes may be filled with the same and/or new bone enhancement material.If this method is applied shortly before insertion of a durableprosthetic implant, the material injected into the bone may be, forexample, a resorbable bone graft substitute, which could provideadditional structural support for the bone when hardened. After bonepreparation, with or without leaving the injection tool in place, thebone could be further prepared using standard instrumentation.

In any embodiment of the present invention, the manifold 416 may be ofrelatively rigid construction, or may instead be at least partially madeof a flexible material, to facilitate bending of the manifold to placethe manifold apertures 418 into desired relationships with the interiorcavities 424 of the insertion structure 838.

While aspects of the present invention have been particularly shown anddescribed with reference to the preferred embodiment above, it will beunderstood by those of ordinary skill in the art that various additionalembodiments may be contemplated without departing from the spirit andscope of the present invention. For example, the specific methodsdescribed above for using the bone preparation apparatus 414 are merelyillustrative; one of ordinary skill in the art could readily determineany number of tools, sequences of steps, or other means/options forplacing the above-described apparatus, or components thereof, intopositions substantively similar to those shown and described herein. Anyof the described structures and components could be integrally formed asa single unitary or monolithic piece or made up of separatesub-components, with either of these formations involving any suitablestock or bespoke components and/or any suitable material or combinationsof materials; however, the chosen material(s) should be biocompatiblefor many applications of the present invention. The mating relationshipsformed between the described structures need not keep the entirety ofeach of the “mating” surfaces in direct contact with each other butcould include spacers or holdaways for partial direct contact, a lineror other intermediate member for indirect contact, or could even beapproximated with intervening space remaining therebetween and nocontact. Though certain components described herein are shown as havingspecific geometric shapes, all structures of the present invention mayhave any suitable shapes, sizes, configurations, relative relationships,cross-sectional areas, or any other physical characteristics asdesirable for a particular application of the present invention. A fluidcould fill one or more interior cavities 424 and remain therein duringsemi-permanent maintenance of the prosthetic implant component 1454within the patient tissue—for example, the interior cavities of theprosthetic implant component could be filled with bone cement, which isthen permitted to harden and thereby strengthen the prosthetic implantcomponent into a relatively solid “block” of material. The bonepreparation apparatus 414 may include a plurality of structurescooperatively forming any components thereof and temporarily orpermanently attached together in such a manner as to permit relativemotion (e.g., pivoting, sliding, or any other motion) therebetween asdesired. Any structures or features described with reference to oneembodiment or configuration of the present invention could be provided,singly or in combination with other structures or features, to any otherembodiment or configuration, as it would be impractical to describe eachof the embodiments and configurations discussed herein as having all ofthe options discussed with respect to all of the other embodiments andconfigurations. A device or method incorporating any of these featuresshould be understood to fall under the scope of the present invention asdetermined based upon the claims below and any equivalents thereof.

Other aspects, objects, and advantages of the present invention can beobtained from a study of the drawings, the disclosure, and the appendedclaims.

1. An apparatus for patient tissue preparation, comprising: a manifoldhaving at least one manifold aperture extending therethrough, themanifold aperture being selectively placed in fluid communication with afluid source; an insertion structure having at least one interior cavityat least partially defined by a structure shell, the interior cavitybeing selectively placed in fluid communication with a correspondingmanifold aperture, the insertion structure being configured forselective placement in a penetrating relationship with a patient tissuebelow a surface of the patient tissue; and at least one shellperforation extending through the structure shell and placing theinterior cavity in fluid communication with a surrounding ambient space;wherein, when the insertion structure is in the penetrating relationshipwith the patient tissue, at least one fluid path extends from the fluidsource, through the manifold aperture, into the interior cavity, throughat least one shell perforation, and at least one of a proximaterelationship and a contacting relationship with the patient tissuebeneath the outer surface thereof; and a fluid is directed along thefluid path to perform a patient tissue preparation task.
 2. Theapparatus of claim 1, wherein the insertion structure is a tube havingproximal and distal tube ends separated by a tube body defining at leasta portion of the interior cavity, the tube body having at least one tubeperforation therethrough serving as a shell perforation, the proximaltube end being selectively placed in fluid communication with the fluidsource through connection with a chosen manifold aperture, the distaltube end being configured for penetrating insertion into the patienttissue with at least one tube perforation located beneath an outersurface of the patient tissue; and wherein a fluid path extends throughthe manifold aperture, into the proximal tube end, through the tubebody, through the tube perforation, and at least one of proximate andcontacting the patient tissue beneath the outer surface thereof.
 3. Theapparatus of claim 1, wherein the insertion structure is temporarilyplaced into the penetrating relationship below the patient tissuesurface during a surgical procedure and is removed from the penetratingrelationship before the surgical procedure ends.
 4. The apparatus ofclaim 1, wherein the insertion structure is at least semi-permanentlyplaced into the penetrating relationship below the patient tissuesurface during a surgical procedure and remains in the penetratingrelationship after the surgical procedure ends.
 5. The apparatus ofclaim 1, including a plurality of interior cavities, with at least oneinterior cavity having a different physical configuration property fromanother one of the interior cavities.
 6. The apparatus of claim 1,including a plurality of shell perforations, with at least one shellperforation having a different physical configuration property fromanother one of the shell perforations.
 7. The apparatus of claim 1,wherein the fluid is controlled to flow in a first direction along afirst fluid path and to flow in a second direction, opposite the firstdirection, along a second fluid path.
 8. The apparatus of claim 1,wherein the patient tissue is altered to accept in a mating relationshipan insertion structure having a particular physical configurationproperty before the insertion structure is placed into the penetratingand mating relationship with the patient tissue.
 9. The apparatus ofclaim 1, wherein, when the insertion structure is in the penetratingrelationship with the patient tissue, at least one fluid path issubstantially separated laterally from at least a portion of at leastone other fluid path by intervening patient tissue.
 10. A method forpatient tissue preparation, comprising the steps of: providing amanifold having at least one manifold aperture extending therethrough;placing the manifold aperture in fluid communication with a fluidsource; providing an insertion structure having at least one interiorcavity at least partially defined by a structure shell; placing theinterior cavity in fluid communication with a corresponding manifoldaperture; selectively placing the insertion structure in a penetratingrelationship with a patient tissue below a surface of the patienttissue; providing at least one shell perforation extending through thestructure shell; placing the interior cavity in fluid communication witha surrounding ambient space through at least one shell perforation; whenthe insertion structure is in the penetrating relationship with thepatient tissue, creating at least one fluid path extending from thefluid source, through the manifold aperture, into the interior cavity,through at least one shell perforation, and at least one of a proximaterelationship and a contacting relationship with the patient tissuebeneath the outer surface thereof; and directing a fluid along the fluidpath to perform a patient tissue preparation task.
 11. The method ofclaim 10, wherein the step of providing an insertion structure includesthe step of providing a tube having proximal and distal tube endsseparated by a tube body defining at least a portion of the interiorcavity; wherein the step of providing at least one shell perforationextending through the structure shell includes the step of providing atleast one tube perforation therethrough; wherein the step of placing theinterior cavity in fluid communication with a corresponding manifoldaperture includes the step of selectively placing the proximal tube endin fluid communication with the fluid source through connection with achosen manifold aperture; wherein the step of selectively placing theinsertion structure in a penetrating relationship with a patient tissuebelow a surface of the patient tissue includes the step of placing thedistal tube end in penetrating insertion into the patient tissue with atleast one tube perforation located beneath an outer surface of thepatient tissue; and wherein the step of creating at least one fluid pathincludes creating a fluid path extending through the manifold aperture,into the proximal tube end, through the tube body, through the tubeperforation, and at least one of proximate and contacting the patienttissue beneath the outer surface thereof.
 12. The method of claim 10,including the steps of: temporarily placing the insertion structure intothe penetrating relationship below the patient tissue surface during asurgical procedure; and removing the insertion structure from thepenetrating relationship before the surgical procedure ends.
 13. Themethod of claim 10, including the steps of: at least semi-permanentlyplacing the insertion structure into the penetrating relationship belowthe patient tissue surface during a surgical procedure; and allowing theinsertion structure to remain in the penetrating relationship after thesurgical procedure ends.
 14. The method of claim 10, wherein the step ofproviding an insertion structure having at least one interior cavityincludes the step of providing an insertion structure having a pluralityof interior cavities, with at least one interior cavity having adifferent physical configuration property from another one of theinterior cavities.
 15. The method of claim 10, wherein the step ofproviding at least one shell perforation includes the step of providinga plurality of shell perforations, with at least one shell perforationhaving a different physical configuration property from another one ofthe shell perforations.
 16. The method of claim 10, including the stepsof: directing a fluid along a first fluid path in a first direction toperform a patient tissue preparation task; and directing a fluid along asecond fluid path in a second direction, opposite the first direction,to perform a patient tissue preparation task.
 17. The method of claim10, including the step of altering the patient tissue to accept in amating relationship an insertion structure having a particular physicalconfiguration property before the insertion structure is placed into thepenetrating and mating relationship with the patient tissue.
 18. Themethod of claim 10, including the step of substantially separating atleast one fluid path laterally from at least one other fluid path byintervening patient tissue when the insertion structure is in thepenetrating relationship with the patient tissue.
 19. A prostheticimplant component installation system, comprising: a manifold having atleast one manifold aperture in a surface thereof, the manifold aperturebeing selectively placed in fluid communication with a fluid source; animplant structure having at least one interior cavity at least partiallydefined by a relatively thin-walled structure shell, the interior cavitybeing selectively placed in fluid communication with a correspondingmanifold aperture, the implant structure being configured for selectiveplacement in a penetrating relationship with a patient tissue below asurface of the patient tissue to provide an ongoing, at leastsemi-permanent therapeutic function to the patient tissue, the implantstructure being selectively mated with the manifold during a surgicalprocedure for fluid communication therewith, and the manifold removedfrom the mating relationship with the implant structure before thesurgical procedure concludes; and at least one shell perforationextending through the structure shell and placing the interior cavity influid communication with a surrounding ambient space; wherein, when theimplant structure is in the penetrating relationship with the patienttissue and the manifold is mated with the implant structure, a pluralityof separate fluid paths are each defined through a chosen manifoldaperture, into a corresponding chosen interior cavity, through at leastone shell perforation of the chosen interior cavity, and into at leastone of a proximate relationship and a contacting relationship with thepatient tissue beneath the outer surface thereof; and a fluid isdirected along at least one fluid path to perform a patient tissuepreparation task.
 20. The system of claim 19, wherein, when theinsertion structure is in the penetrating relationship with the patienttissue, at least one fluid path is substantially separated laterallyfrom at least a portion of at least one other fluid path by interveningpatient tissue.
 21. The system of claim 19, wherein the interior cavityis at least partially defined by a relatively thin-walled structureshell such that a higher percentage of the total implant structurevolume is dedicated to interior cavity space than is provided by thestructure shell.